Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis

Airway Obstruction Clinical Trial

Official title:

The Comparison of Voice and Swallowing Parameters After Endoscopic Total and Partial Arytenoidectomy Using Medially Based Mucosal Advancement Flap Technique for Bilateral Abductor Vocal Fold Paralysis: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824849
• Other study ID #: HUmedTY1
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: April 4, 2013
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Total arytenoidectomy is claimed to increase risk of aspiration and cause more voice loss than other operations performed for bilateral vocal fold paralysis (BVFP). However, objective evidence for such conclusion is lacking. There is no study comparing swallowing and voice after total and partial arytenoidectomy.

Description:

Design: Prospective, randomized, double-blind, case-control Setting: Tertiary, referral, university Patients: Twenty patients with BVFP Intervention: Endoscopic total and partial arytenoidectomy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Bilateral vocal fold paralysis

Exclusion Criteria:

• Previously operated patients

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Obstruction
• Paralysis
• Vocal Cord Paralysis

Intervention

Procedure:
• Total arytenoidectomy
Endoscopic total arytenoidectomy was performed on patients with bilateral vocal fold paralysis
• Partial arytenoidectomy
Endoscopic partial arytenoidectomy was performed on patients with bilateral vocal fold paralysis

Locations

Country	Name	City	State
Turkey	Hacettepe University Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

Bosley B, Rosen CA, Simpson CB, McMullin BT, Gartner-Schmidt JL. Medial arytenoidectomy versus transverse cordotomy as a treatment for bilateral vocal fold paralysis. Ann Otol Rhinol Laryngol. 2005 Dec;114(12):922-6. — View Citation

Crumley RL. Endoscopic laser medial arytenoidectomy for airway management in bilateral laryngeal paralysis. Ann Otol Rhinol Laryngol. 1993 Feb;102(2):81-4. — View Citation

Dursun G, Gökcan MK. Aerodynamic, acoustic and functional results of posterior transverse laser cordotomy for bilateral abductor vocal fold paralysis. J Laryngol Otol. 2006 Apr;120(4):282-8. — View Citation

Hillel AD, Benninger M, Blitzer A, Crumley R, Flint P, Kashima HK, Sanders I, Schaefer S. Evaluation and management of bilateral vocal cord immobility. Otolaryngol Head Neck Surg. 1999 Dec;121(6):760-5. Review. — View Citation

Kleinsasser O, Nolte E. [Report on the indication, technique and functional results of endolaryngeal arytenoidectomy and submucous partial chordectomy in bilateral paralysis of vocal cord (author's transl)]. Laryngol Rhinol Otol (Stuttg). 1981 Aug;60(8):397-401. German. — View Citation

Plouin-Gaudon I, Lawson G, Jamart J, Remacle M. Subtotal carbon dioxide laser arytenoidectomy for the treatment of bilateral vocal fold immobility: long-term results. Ann Otol Rhinol Laryngol. 2005 Feb;114(2):115-21. — View Citation

Remacle M, Lawson G, Mayné A, Jamart J. Subtotal carbon dioxide laser arytenoidectomy by endoscopic approach for treatment of bilateral cord immobility in adduction. Ann Otol Rhinol Laryngol. 1996 Jun;105(6):438-45. — View Citation

Salassa JR. A functional outcome swallowing scale for staging oropharyngeal dysphagia. Dig Dis. 1999;17(4):230-4. Review. — View Citation

Sapundzhiev N, Lichtenberger G, Eckel HE, Friedrich G, Zenev I, Toohill RJ, Werner JA. Surgery of adult bilateral vocal fold paralysis in adduction: history and trends. Eur Arch Otorhinolaryngol. 2008 Dec;265(12):1501-14. doi: 10.1007/s00405-008-0665-1. Epub 2008 Apr 17. — View Citation

THORNELL WC. Transoral intralaryngeal approach for arytenoidectomy in bilateral vocal cord paralysis with inadequate airway. Ann Otol Rhinol Laryngol. 1957 Jun;66(2):364-8. — View Citation

Yilmaz T. Endoscopic total arytenoidectomy for bilateral abductor vocal fold paralysis: a new flap technique and personal experience with 50 cases. Laryngoscope. 2012 Oct;122(10):2219-26. doi: 10.1002/lary.23467. Epub 2012 Aug 2. — View Citation

Young VN, Rosen CA. Arytenoid and posterior vocal fold surgery for bilateral vocal fold immobility. Curr Opin Otolaryngol Head Neck Surg. 2011 Dec;19(6):422-7. doi: 10.1097/MOO.0b013e32834c1f1c. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Voice Handicap Index	Voice Handicap Index is a 30-item questionnaire. Possible points change between 0 to 120. Zero means normal voice, 120 means the worst voice. Preoperative examinations were repeated 1 year after surgery.	From the day of operation until 52 weeks after arytenoidectomy	No
Other	Acoustic analysis	Fundamental frequency (Hertz), absolute jitter (microseconds), shimmer percent (%), noise to harmonic ratio will be measured as physical measures of voice.	From the day operation until 52 weeks after arytenoidectomy	No
Other	Aerodynamic analysis	Maximum phonation time (seconds), mean flow rate (liters/second), mean resistance (cmH20/liter/second), mean power (Watt), mean efficiency (ppm) and mean pressure (cmH2O)are obtained as physical measures of aerodynamic analysis.	From the day of operation until 52 weeks after arytenoidectomy	No
Other	Postoperative breathing ability	Breathing ability was evaluated on a scale of -2 to +2 (-2: significantly worse; -1: somewhat worse; 0: no change; +1: somewhat better; +2: significantly better).	52 weeks after arytenoidectomy	No
Other	Subjective comparison of pre- and postoperative voice by a phoniatrician	Subjective comparison of pre- and postoperative voice on a scale of -2 to +2 (-2: significantly worse; -1: somewhat worse; 0: no change; +1: somewhat better; +2: significantly better).	From the day of operation until 52 weeks after arytenoidectomy	No
Other	Speech intensity	Speech intensity is measured in decibels.	52 weeks after arytenoidectomy	No
Other	Functional outcome swallowing scale	Functional Outcome Swallowing Scale: 0-5 (0: Normal function and asymptomatic; 1: Normal function with episodic or daily symptoms of dysphagia; 2: Compensated abnormal function manifested by significant dietary modifications or prolonged mealtime (without weight loss or aspiration); 3: Decompensated abnormal function with weight loss of <10% of body weight over 6 months due to dysphagia; or daily cough, gagging or aspiration during meals; 4: Severely decompensated abnormal function with weight loss of >10% of body weight over 6 months due to dysphagia; or severe aspiration with bronchopulmonary complications. Non oral feeding for most nutrition; 5: Non oral feeding for all nutrition).	52 weeks after arytenoidectomy	No
Primary	Decannulation	Preoperative examinations were repeated 1 year after surgery.	From the day of operation until 52 weeks after arytenoidectomy	No
Secondary	Duration of operation	The duration of operation was measured in minutes at the day of operation.	At the day of operation	No